Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43) | RFA AR 18 005

Opportunity Information: Apply for RFA AR 18 005

The Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43) opportunity (Funding Opportunity Number RFA-AR-18-005) is a National Institutes of Health (NIH) discretionary grant program designed to help small business concerns move early-stage, preclinical biomedical innovations toward practical products. The focus is specifically on rare diseases affecting the musculoskeletal system, rheumatic conditions, and skin disorders, with "rare" defined using the standard U.S. threshold of fewer than 200,000 affected individuals. In plain terms, the FOA is aimed at companies that are building or refining tools and therapeutic approaches for patient populations that are often underserved because the market is small and traditional investment can be harder to secure.

The scientific scope centers on preclinical studies that advance development in two main areas: biomarkers and treatments. Biomarkers can include measurable indicators that help diagnose a disease earlier, predict how it will progress, identify which patients are most likely to respond to a therapy, or track whether a treatment is working. On the treatment side, the FOA supports work that moves potential therapies forward before human trials, such as proof-of-concept efficacy studies, dose exploration in relevant models, optimization of leads, and other foundational activities that strengthen the case for eventual clinical development. The solicitation also explicitly includes studies involving FDA-designated orphan products, as long as they relate to musculoskeletal, rheumatic, or skin diseases. That detail matters because it signals interest not only in novel inventions, but also in advancing products that may already have an orphan designation pathway and a clearer regulatory context.

Eligibility is restricted to small businesses, consistent with the SBIR program rules, and the award mechanism is the NIH R43, which is the Phase I SBIR grant mechanism. Phase I typically supports feasibility and early proof-of-concept work rather than large-scale development, and this FOA is framed around that preclinical, early advancement stage. The listing indicates an award ceiling of $225,000, setting expectations for the scale of work that can be supported under this specific announcement. The program is categorized under health and is associated with CFDA number 93.846, which aligns it with NIH extramural funding in the relevant institute area.

The FOA includes clear limitations related to foreign participation. Non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply either. At the same time, it notes that "foreign components" may be allowed as defined in the NIH Grants Policy Statement. Practically, that means the applicant organization must be a U.S.-based eligible small business, but certain project elements may potentially be carried out abroad if they meet NIH definitions and requirements, are well justified, and comply with NIH policy. This kind of structure is common when a specialized assay, model, or resource is only available outside the U.S., but the primary control and responsibility for the project must remain with the eligible U.S. small business applicant.

Key administrative details in the provided source data include an original closing date of July 10, 2017, and a creation date of April 11, 2017. The announcement is presented as a targeted solicitation for rare disease-related R&D rather than a broad, general SBIR call, which usually means the funding institute is signaling particular interest in advancing concrete translational programs in these disease areas. In short, the opportunity is meant to help U.S. small businesses generate the preclinical evidence needed to de-risk and accelerate biomarker or therapeutic candidates for rare musculoskeletal, rheumatic, and skin diseases, including candidates that fall under the FDA orphan product framework.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
• This funding opportunity was created on 2017-04-11.
• Applicants must submit their applications by 2017-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA AR 18 005

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